Panels › Ear, Nose, Throat › Product code MIX · Class 2
System, Vocal Cord Medialization
Regulation 874.3620
0510(k)s in 12 months (17 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in MIX
| Company | 510(k)s | Recalls |
|---|---|---|
| Cytophil, Inc. | 4 | 0 |
| Coapt Systems, Inc. | 3 | 0 |
| Bioform Medical, Inc. | 2 | 0 |
| Smith & Nephew, Inc. | 2 | 0 |
| Sofregen Medical | 2 | 0 |
| Bioform, Inc. | 1 | 0 |
| Biomet, Inc. | 1 | 0 |
| Boston Medical Products, Inc. | 1 | 0 |
| Merz North America, Inc. | 0 | 1 |
| W. L. Gore & Associates, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 3, 2015 | Merz North America, Inc. PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable implant material to aid in surgical reconstructions as a space occupying material in laryngeal surgical procedures for vocal fo Terminated |
MIX | K060815 |
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